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carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol ®-XR
(carbamazepine extended-release tablets)
100 mg, 200 mg, 400 mg
Rx only
Prescribing Information
WARNINGS
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE
SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC
EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN
REPORTED DURING TREATMENT WITH TEGRETOL. THESE REACTIONS ARE ESTIMATED TO
OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN
POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10
TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG
ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF
HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND
ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA.
PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED
FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH TEGRETOL.
PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH TEGRETOL
UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE WARNINGS AND PRECAUTIONS,
LABORATORY TESTS).
APLASTIC ANEMIA AND AGRANULOCYTOSIS
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH
THE USE OF TEGRETOL. DATA FROM A POPULATION-BASED CASE CONTROL STUDY
DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5 TO 8 TIMES GREATER
THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS
IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE
MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE
MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA.
ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE
BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF TEGRETOL,
DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME.
HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO
THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA,
THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF
PATIENTS ON TEGRETOL ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER
ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING
SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT
DESCRIPTION
Tegretol, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for
oral administration as chewable tablets of 100 mg, tablets of 200 mg, XR tablets of 100, 200, and 400 mg, and
as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f ]azepine-5-carboxamide, and
its structural formula is:
Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in
acetone. Its molecular weight is 236.27.
Inactive Ingredients Tablets: Colloidal silicon dioxide, D&C Red No. 30 Aluminum Lake (chewable tablets
only), FD&C Red No. 40 (200 mg tablets only), flavoring (chewable tablets only), gelatin, glycerin, magnesium
stearate, sodium starch glycolate (chewable tablets only), starch, stearic acid, and sucrose (chewable tablets
only). Suspension: Citric acid, FD&C Yellow No. 6, flavoring, polymer, potassium sorbate, propylene glycol,
purified water, sorbitol, sucrose, and xanthan gum. Tegretol-XR tablets: cellulose compounds, dextrates, iron
oxides, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (200 mg
tablets only).
CLINICAL PHARMACOLOGY
In controlled clinical trials, Tegretol has been shown to be effective in the treatment of psychomotor and grand
mal seizures, as well as trigeminal neuralgia.
Mechanism of Action
Tegretol has demonstrated anticonvulsant properties in rats and mice with electrically and chemically induced
seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation.
Tegretol greatly reduces or abolishes pain induced by stimulation of the infraorbital nerve in cats and rats. It
depresses thalamic potential and bulbar and polysynaptic reflexes, including the linguomandibular reflex in
cats. Tegretol is chemically unrelated to other anticonvulsants or other drugs used to control the pain of
trigeminal neuralgia. The mechanism of action remains unknown.
The principal metabolite of Tegretol, carbamazepine-10,11-epoxide, has anticonvulsant activity as
demonstrated in several in vivo animal models of seizures. Though clinical activity for the epoxide has been
postulated, the significance of its activity with respect to the safety and efficacy of Tegretol has not been
established.
Pharmacokinetics
In clinical studies, Tegretol suspension, conventional tablets, and XR tablets delivered equivalent amounts of
drug to the systemic circulation. However, the suspension was absorbed somewhat faster, and the XR tablet
slightly slower, than the conventional tablet. The bioavailabilityof the XR tablet was 89% compared to
suspension. Following a twice a day dosage regimen, the suspension provides higher peak levels and lower
CONTRAINDICATIONS
Tegretol should not be used in patients with a history of previous bone marrow depression, hypersensitivity to
the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine,
imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase
WARNINGS
Serious Dermatologic Reactions
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens -
Johnson syndrome (SJS), have been reported with Tegretol treatment. The risk of these events is estimated to be
about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some
Asian countries is estimated to be about 10 times higher. Tegretol should be discontinued at the first sign of a
rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should
not be resumed and alternative therapy should be considered.
SJS/TEN and HLA-B*1502 Allele
Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association
between the risk of developing SJS/TEN with carbamazepine treatment and the presence of an inherited variant
of the HLA-B gene, HLA-B*1502. The occurrence of higher rates of these reactions in countries with higher
frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity.
Across Asian populations, notable variation exists in the prevalence of HLA-B*1502. Greater than 15% of the
population is reported positive in Hong Kong, Thailand, Malaysia, and parts of the Philippines, compared to
about 10% in Taiwan and 4% in North China. South Asians, including Indians, appear to have intermediate
prevalence of HLA-B*1502, averaging 2% to 4%, but higher in some groups. HLA-B*1502 is present in less
than 1% of the population in Japan and Korea.
HLA-B*1502 is largely absent in individuals not of Asian origin (e.g., Caucasians, African-Americans,
Hispanics, and Native Americans).
Prior to initiating Tegretol therapy, testing for HLA-B*1502 should be performed in patients with
ancestry in populations in which HLA-B*1502 may be present. In deciding which patients to screen, the
rates provided above for the prevalence of HLA-B*1502 may offer a rough guide, keeping in mind the
limitations of these figures due to wide variability in rates even within ethnic groups, the difficulty in
ascertaining ethnic ancestry, and the likelihood of mixed ancestry. Tegretol should not be used in patients
positive for HLA-B*1502 unless the benefits clearly outweigh the risks. Tested patients who are found to be
negative for the allele are thought to have a low risk of SJS/TEN (see BOXED WARNING and
PRECAUTIONS, Laboratory Tests).
Over 90% of Tegretol treated patients who will experience SJS/TEN have this reaction within the first few
months of treatment. This information may be taken into consideration in determining the need for screening of
genetically at-risk patients currently on Tegretol.
The HLA-B*1502 allele has not been found to predict risk of less severe adverse cutaneous reactions from
Tegretol such as maculopapular eruption (MPE) or to predict Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS).
Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients
of Chinese ancestry taking other antiepileptic drugs associated with SJS/TEN, including phenytoin.
Consideration should be given to avoiding use of other drugs associated with SJS/TEN in HLA-B*1502
positive patients, when alternative therapies are otherwise equally acceptable.
Hypersensitivity
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan
hypersensitivity, has occurred with Tegretol. Some of these events have been fatal or life-threatening. DRESS
typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in
association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities,
myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. This
disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to
note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though
rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Tegretol
should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Hypersensitivity
Hypersensitivity reactions to carbamazepine have been reported in patients who previously experienced this
reaction to anticonvulsants including phenytoin, primidone, and phenobarbital. If such history is present,
benefits and risks should be carefully considered and, if carbamazepine is initiated, the signs and symptoms of
hypersensitivity should be carefully monitored.
Patients should be informed that about a third of patients who have had hypersensitivity reactions to
Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelids have been reported in
patients after taking the first or subsequent doses of Tegretol. Angioedema associated with laryngeal edema can
General
PRECAUTIONS
General
Before initiating therapy, a detailed history and physical examination should be made.
Tegretol should be used with caution in patients with a mixed seizure disorder that includes atypical absence
seizures, since in these patients Tegretol has been associated with increased frequency of generalized
convulsions (see INDICATIONS AND USAGE).
Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac
conduction disturbance, including second- and third-degree AV heart block; cardiac, hepatic, or renal damage;
adverse hematologic or hypersensitivity reaction to other drugs, including reactions to other anticonvulsants; or
interrupted courses of therapy with Tegretol.
AV heart block, including second- and third-degree block, have been reported following Tegretol treatment.
This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for
conduction disturbances.
Hepatic effects, ranging from slight elevations in liver enzymes to rare cases of hepatic failure have been
reported (see ADVERSE REACTIONS and PRECAUTIONS, Laboratory Tests). In some cases, hepatic effects
may progress despite discontinuation of the drug. In addition rare instances of vanishing bile duct syndrome
have been reported. This syndrome consists of a cholestatic process with a variable clinical course ranging from
fulminant to indolent, involving the destruction and disappearance of the intrahepatic bile ducts. Some, but not
all, cases are associated with features that overlap with other immunoallergenic syndromes such as multiorgan
hypersensitivity (DRESS syndrome) and serious dermatologic reactions. As an example there has been a report
of vanishing bile duct syndrome associated with Stevens-Johnson syndrome and in another case an association
with fever and eosinophilia.
Since a given dose of Tegretol suspension will produce higher peak levels than the same dose given as the
tablet, it is recommended that patients given the suspension be started on lower doses and increased slowly to
avoid unwanted side effects (see DOSAGE AND ADMINISTRATION).
Tegretol suspension contains sorbitol and, therefore, should not be administered to patients with rare hereditary
problems of fructose intolerance.
Information for Patients
Patients should be informed of the availability of a Medication Guide and they should be instructed to read the
Medication Guide before taking Tegretol.
Patients should be made aware of the early toxic signs and symptoms of a potential hematologic problem, as
well as dermatologic, hypersensitivity or hepatic reactions. These symptoms may include, but are not limited to,
fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric
hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. The patient should be
advised that, because these signs and symptoms may signal a serious reaction, that they must report any
Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This
registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients
can call the toll free number 1-888-233-2334 (see WARNINGS, Usage in Pregnancy subsection).
Laboratory Tests
For genetically at-risk patients (see WARNINGS), high-resolution ‘HLA-B*1502 typing’ is recommended. The
test is positive if either one or two HLA-B*1502 alleles are detected and negative if no HLA-B*1502 alleles are
detected.
Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, should be
obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or
platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any
evidence of significant bone marrow depression develops.
Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, mus t
be performed during treatment with this drug since liver damage may occur (see PRECAUTIONS, General and
ADVERSE REACTIONS). Carbamazepine should be discontinued, based on clinical judgment, if indicated by
newly occurring or worsening clinical or laboratory evidence of liver dysfunction or hepatic damage, or in the
case of active liver disease.
Baseline and periodic eye examinations, including slit-lamp, funduscopy, and tonometry, are recommended
since many phenothiazines and related drugs have been shown to cause eye changes.
Baseline and periodic complete urinalysis and BUN determinations are recommended for patients treated with
this agent because of observed renal dysfunction.
Monitoring of blood levels (see CLINICAL PHARMACOLOGY) has increased the efficacy and safety of
anticonvulsants. This monitoring may be particularly useful in cases of dramatic increase in seizure frequency
and for verification of compliance. In addition, measurement of drug serum levels may aid in determining the
cause of toxicity when more than one medication is being used.
Thyroid function tests have been reported to show decreased values with Tegretol administered alone.
ADVERSE REACTIONS
If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that
abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even
status epilepticus with its life-threatening hazards.
The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED
WARNING), the liver, and the cardiovascular system.
The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness,
drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should
be initiated at the lowest dosage recommended.
The following additional adverse reactions have been reported:
Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression,
thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria,
porphyria cutanea tarda.
Liver: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of
hepatic failure.
Pancreatic: Pancreatitis.
Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.
Genitourinary System: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure,
azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the
urine have also been reported. There have been rare reports of impaired male fertility and/or abnormal
spermatogenesis.
Testicular atrophy occurred in rats receiving Tegretol orally from 4 to 52 weeks at dosage levels of 50 to 400
mg/kg/day. Additionally, rats receiving Tegretol in the diet for 2 years at dosage levels of 25, 75, and 250
mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a
brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and
higher. Relevance of these findings to humans is unknown.
Nervous System: Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred
vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances,
abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness,
tinnitus, hyperacusis, neuroleptic malignant syndrome.
There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the
exact relationship of these reactions to the drug has not been established.
Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomitant use of
psychotropic drugs.
Digestive System: Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and
dryness of the mouth and pharynx, including glossitis and stomatitis.
Eyes: Scattered punctate cortical lens opacities, increased intraocular pressure (see WARNINGS, General) as
well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many
phenothiazines and related drugs have been shown to cause eye changes.
Musculoskeletal System: Aching joints and muscles, and leg cramps.
Metabolism: Fever and chills. Hyponatremia (see WARNINGS, General). Decreased levels of plasma calcium
have been reported. Osteoporosis has been reported.
Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports
of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants.
A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a
patient taking carbamazepine in combination with other medications. The patient was successfully
dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.
OVERDOSAGE
Acute Toxicity
Lowest known lethal dose: adults, 3.2 g (a 24-year-old woman died of a cardiac arrest and a 24-year-old man
died of pneumonia and hypoxic encephalopathy); children, 4 g (a 14-year-old girl died of a cardiac arrest), 1.6 g
(a 3-year-old girl died of aspiration pneumonia).
Oral LD50 in animals (mg/kg): mice, 1100 to 3750; rats, 3850 to 4025; rabbits, 1500 to 2680; guinea pigs, 920.
Signs and Symptoms
The first signs and symptoms appear after 1 to 3 hours. Neuromuscular disturbances are the most prominent.
Cardiovascular disorders are generally milder, and severe cardiac complications occur only when very high
doses (greater than 60 g) have been ingested.
Respiration: Irregular breathing, respiratory depression.
Cardiovascular System: Tachycardia, hypotension or hypertension, shock, conduction disorders.
Nervous System and Muscles: Impairment of consciousness ranging in severity to deep coma. Convulsions,
especially in small children. Motor restlessness, muscular twitching, tremor, athetoid movements, opisthotonos,
ataxia, drowsiness, dizziness, mydriasis, nystagmus, adiadochokinesia, ballism, psychomotor disturbances,
dysmetria. Initial hyperreflexia, followed by hyporeflexia.
Gastrointestinal Tract: Nausea, vomiting.
Kidneys and Bladder: Anuria or oliguria, urinary retention.
Laboratory Findings: Isolated instances of overdosage have included leukocytosis, reduced leukocyte count,
glycosuria, and acetonuria. EEG may show dysrhythmias.
Combined Poisoning: When alcohol, tricyclic antidepressants, barbiturates, or hydantoins are taken at the same
time, the signs and symptoms of acute poisoning with Tegretol may be aggravated or modified.
Treatment
The prognosis in cases of severe poisoning is critically dependent upon prompt elimination of the drug, which
may be achieved by inducing vomiting, irrigating the stomach, and by taking appropriate steps to diminish
absorption. If these measures cannot be implemented without risk on the spot, the patient should be transferred
at once to a hospital, while ensuring that vital functions are safeguarded. There is no specific antidote.
Elimination of the Drug: Induction of vomiting.
Gastric lavage. Even when more than 4 hours have elapsed following ingestion of the drug, the stomach should
be repeatedly irrigated, especially if the patient has also consumed alcohol.
Measures to Reduce Absorption: Activated charcoal, laxatives.
Measures to Accelerate Elimination: Forced diuresis.
Dialysis is indicated only in severe poisoning associated with renal failure. Replacement transfusion is indicate d
in severe poisoning in small children.
Respiratory Depression: Keep the airways free; resort, if necessary, to endotracheal intubation, artificial
Hypotension, Shock: Keep the patient’s legs raised and administer a plasma expander. If blood pressure fails to
rise despite measures taken to increase plasma volume, use of vasoactive substances should be considered.
Reference ID: 4236702
Convulsions: Diazepam or barbiturates.
Warning: Diazepam or barbiturates may aggravate respiratory depression (especially in children), hypotension,
and coma. However, barbiturates should not be used if drugs that inhibit monoamine oxidase have also been
taken by the patient either in overdosage or in recent therapy (within 1 week).
Surveillance: Respiration, cardiac function (ECG monitoring), blood pressure, body temperature, pupillary
reflexes, and kidney and bladder function should be monitored for several days.
Treatment of Blood Count Abnormalities: If evidence of significant bone marrow depression develops, the
following recommendations are suggested: (1) stop the drug, (2) perform daily CBC, platelet, and reticulocyte
counts, (3) do a bone marrow aspiration and trephine biopsy immediately and repeat with sufficient frequency
to monitor recovery.
Special periodic studies might be helpful as follows: (1) white cell and platelet antibodies, (2) 59Fe-ferrokinetic
studies, (3) peripheral blood cell typing, (4) cytogenetic studies on marrow and peripheral blood, (5) bone
marrow culture studies for colony-forming units, (6) hemoglobin electrophoresis for A2 and F hemoglobin, and
(7) serum folic acid and B12 levels.
A fully developed aplastic anemia will require appropriate, intensive monitoring and therapy, for which
Do not store above 30°C (86°F). Protect from light and moisture.
Tablets 200 mg - capsule-shaped, pink, single-scored (imprinted Tegretol on one side and 27 twice on the
XR Tablets 100 mg - round, yellow, coated (imprinted T on one side and 100 mg on the other), release portal on
one side
Bottles of 100 ............................................................................................................................ NDC 0078-0510-05
XR Tablets 200 mg - round, pink, coated (imprinted T on one side and 200 mg on the other), release portal on
one side
Bottles of 100 ............................................................................................................................ NDC 0078-0511-05
XR Tablets 400 mg - round, brown, coated (imprinted T on one side and 400 mg on the other), release portal on
one side
Bottles of 100 ............................................................................................................................ NDC 0078-0512-05
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Protect from moisture.
Dispense in tight container (USP).
Suspension 100 mg/5 mL (teaspoon) – yellow-orange, citrus-vanilla flavored
Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).
T201X-XX
March 2018
(carbamazepine)
Tablets, Suspension, Chewable Tablets, Extended-Release Tablets
Read this Medication Guide before you start taking Tegretol or Tegretol–XR (TEGRETOL) and each time you
get a refill. There may be new information. This information does not take the place of talking to your
healthcare provider about your medical condition or treatment.
skin rash
hives
2. TEGRETOL may cause rare but serious blood problems. Symptoms may include:
fever, sore throat, or other infections that come and go or do not go away
easy bruising
red or purple spots on your body
bleeding gums or nose bleeds
severe fatigue or weakness
3. TEGRETOL may cause allergic reactions or serious problems, which may affect organs and
other parts of your body like the liver or blood cells. You may or may not have a rash with these
types of reactions.
Call your healthcare provider right away if you have any of the following:
4. Like other antiepileptic drugs, TEGRETOL may cause suicidal thoughts or actions in a very
small number of people, about 1 in 500.
Call your healthcare provider right away if you have any of these symptoms, especially if they
are new, worse, or worry you:
panic attacks
How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Call your healthcare provider between visits as needed, especially if you are w orried about symptoms.
What is TEGRETOL?
TEGRETOL is a prescription medicine used to treat:
TEGRETOL is not a regular pain medicine and should not be used for aches or pains.
▪ If you become pregnant while taking TEGRETOL, talk to your healthcare provider about registering
with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry
is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in
this registry by calling 1-888-233-2334.
are breastfeeding or plan to breastfeed. TEGRETOL passes into breast milk. You and your healthcare
provider should discuss whether you should take TEGRETOL or breastfeed; you should not do both.
Tell your healthcare provider about all the medicines you take , including prescription and non-prescription
medicines, vitamins, and herbal supplements.
Taking TEGRETOL with certain other medicines may cause side effects or affect how well they work. Do not
start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when
you get a new medicine.
Tell your healthcare provider if you can not swallow TEGRETOL-XR whole.
TEGRETOL Suspension:
Do not take TEGRETOL suspension at the same time you take other liquid medicines.
If you take too much TEGRETOL, call your healthcare provider or local Poison Control Center right away.
What should I avoid while taking TEGRETOL?
Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking TEGRETOL until
you talk to your healthcare provider. TEGRETOL taken with alcohol or drugs that cause sleepiness or
dizziness may make your sleepiness or dizziness worse.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how
TEGRETOL affects you. TEGRETOL may slow your thinking and motor skills.
See “What is the most important information I should know about TEGRETOL?”
Get medical help right away if you have any of the symptoms listed above or listed in “What is the most
important information I should know about TEGRETOL?”
nausea
vomiting
These are not all the possible side effects of TEGRETOL. For more information, ask your healthcare provider
or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA
1088.
Store TEGRETOL-XR Tablets at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Keep TEGRETOL-XR Tablets dry.
Do not store TEGRETOL Suspension above 30°C (86°F).
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
© Novartis
T201X-XX/T201X-XX
March 2018